Continuous Monitoring of Body Temperature in Mothers and Their Preterm Neonates

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMedical University of Graz

About this trial

Preterm babies are at increased risk of becoming too cold or too warm immediately after birth because they have an immature ability to regulate their body temperature. Maintaining a normal body temperature during the first minutes after birth is important because both low and high body temperatures are associated with an increased risk of complications. Current temperature monitoring is performed intermittently using conventional thermometers and does not provide continuous information about changes in body temperature.

This prospective observational pilot study aims to evaluate the feasibility of using the SteadyTemp® adhesive thermometer, a wireless, non-invasive temperature sensor, for continuous body temperature monitoring in preterm neonates (32+0 to 36+6 weeks of gestation) during the first 15 minutes after birth. The study will also compare temperatures recorded by the adhesive thermometer with a routine rectal temperature measurement and assess skin tolerability after removal of the adhesive patch. In addition, maternal body temperature will be continuously monitored during delivery to explore the relationship between maternal intrapartum temperature and neonatal temperature during the immediate postnatal transition.

The study hypothesizes that continuous temperature monitoring with the SteadyTemp® adhesive thermometer is feasible in preterm neonates, that the recorded temperatures agree with standard rectal temperature measurements, that the device is well tolerated without clinically relevant skin irritation, and that maternal intrapartum temperature correlates with neonatal body temperature during the immediate postnatal transition. The results of this pilot study will provide preliminary evidence to support future studies evaluating continuous, non-invasive temperature monitoring as a tool to improve thermal management of preterm neonates immediately after birth.

Eligibility criteria

Qualifiers

Preterm neonates born between 32+0 and 36+6 weeks of gestation.

Written informed consent obtained from the mother (or legally authorized representative, where applicable according to national legislation) before delivery and before any study-specific procedures are performed.

Disqualifiers

Gestational age <32+0 weeks or ≥37+0 weeks.

No decision to conduct full life support.

Written informed consent not obtained before delivery.

Congenital malformation.

Trial design

Treatments tested in this trial

  • Temperature monitoring

Treatment groups

40 Participants
are divided into 1 treatment group

Sponsors and collaborators

Medical University of Graz

Lead sponsor

Universität Duisburg-Essen

Collaborator